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Appendix B: Executive Summary of *A National Cancer Clinical Trials System for the 21st Century*
Pages 89-92

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From page 89...
... For example, companies may have less incentive to •  onduct clinical trials to compare the effectiveness of different treat c ment options that are already approved for clinical use, •  ombine novel therapies developed by different sponsors, c • develop therapies for rare diseases, • determine optimal duration and dose of treatment with drugs in clinical use, • test multimodality therapies, such as radiation therapy, surgery, or devices in combination with drugs, • study screening and prevention strategies, or • focus on rehabilitation and quality of life following therapy. The National Cancer Institute (NCI)
From page 90...
... The committee concluded that a robust, standing cancer clinical trials network is essential to effectively translate discoveries into clinical benefits for patients. There are hundreds of cancer therapies in development and a continuous need for design and implementation of new clinical trials, so it would be highly inefficient to fund and develop infrastructures and research teams separately for each new trial.
From page 91...
... In addition, government agencies need to streamline and coordinate the oversight process, with parallel, concurrent, or ideally, joint reviews to the extent possible. In sum, the academic, government, and commercial sectors must join with the public to develop a 21st-century multidisciplinary clinical trials system to more effectively leverage scientific advancements and translate them into public health benefits by improving the science; technology; efficiency; and timely creation, launch, and completion of the highest-priority cancer clinical trials.
From page 92...
... Cover the cost of patient care in clinical trials a Front office operations refer primarily to the Cooperative Group scientific committees and statistical offices, which are responsible for activities such as trial design, prioritization, and data analysis. b Back office operations refer to administrative structures and activities that include such things as data collection and management, data queries and reviews, patient registration, audit functions, case report form processing, image storage and retrieval, drug distribution, credentialing of sites, and funding and reimbursement for patient accrual.


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